Principal Clinical Research Scientist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Irvine California United States of America Jacksonville Florida United States of America Milpitas California United States of America

Job Description:

JOB POSITION SUMMARY

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Are you passionate about improving and expanding the possibilities of vision treatments Ready to join a team thats reimagining how vision is improved Our Vision team solves the toughest health challenges. Help combine cutting-edge insights science technology and people to encourage eye care professionals and patients to proactively protect correct and enhance healthy sight for life. Our products and services address these needs from the pediatric to aging eye in a patients lifetime. Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent to join our Vision team as Principal Clinical Research Scientist J&J Vision located preferably in Jacksonville FL Milpitas CA or Irvine CA.

Purpose:

The Principal Clinical Research Scientist for Vision is an expert in ophthalmic and medical device research who serves as a core team member on key projects and leads a team of Staff Clinical Scientist. This role provides strategic and scientific leadership for the development and execution of clinical programs that generate robust evidence to support innovative vision care products and technologies. Leveraging deep expertise in clinical research product development and ophthalmic regulations the Principal Clinical Research Scientist influences development strategies aligns cross-functional stakeholders and drives successful execution of complex initiatives that improve outcomes for eye care professionals and their patients.

You will be responsible for:

Represent Clinical Science as core team member on critical projects liaising

between project and functional teams and coordinating with Clinical Operations

and Project Management partners to deliver on time within budget and in

compliance with regulations and SOPs.

Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g. Global Strategic Marketing Medical Affairs Regulatory Affairs R&D etc.) to ensure consistent alignment in new product development and through product life cycle.

Lead initiatives for appropriate interpretation and dissemination of all evidence generated including Clinical Study Reports abstracts manuscripts and MDR-related documents (CER PMCF Clinical Plans etc.).

Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy including proposed investigations review process of evidence to support marketing authorization and support of regulatory inspections

Engage and collaborate with industrys key opinion leaders including KOLs and regulatory agencies and build on relationships established through professional/technical societies

Performs other related duties as assigned by management.

Qualifications / Requirements:

Education

• Advanced degree in scientific discipline (required)

• OD MD/Ophthalmologist or PhD in Vision Science/related field strongly preferred

• Post-graduate training residency or fellowship preferred

Ophthalmic Expertise

• 5 years of ophthalmic clinical research experience

• Deep understanding of eye care ophthalmic devices vision science or related therapeutic areas

• Experience supporting product development and lifecycle management

Clinical Research Leadership

• Led clinical studies or clinical programs not just participated in them

• Experience designing studies and selecting endpoints

• Demonstrated leadership on complex cross-functional projects

Technical Writing

Personally authored or substantially contributed to:

• Clinical study protocols

• Clinical Study Reports (CSRs)

• Scientific abstracts

• Manuscripts/publications

Scientific & Statistical Acumen

• Can interpret study results independently

• Comfortable working with biostatisticians on:

• Sample size assumptions

• Endpoint strategy

• Statistical analysis plans

• Interpretation of results

Communication & Influence

• Demonstrated ability to influence without direct authority

• Experience partnering with R&D Regulatory Affairs Marketing Medical Affairs and Clinical Operations

REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES AND AFFILIATIONS

• Strong technical writing ability such as clinical study protocols reports and abstracts is required

• Understanding of biostatistics as applied to study data is required

• Proficient with computers and software programs is required

TRAVEL REQUIREMENTS

Up to 10% of domestic or international travel is required

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Clinical Evaluations Coaching Critical Thinking Drug Discovery Development Entrepreneurship Good Clinical Practice (GCP) Leadership Medicines and Device Development and Regulation Organizing Regulatory Affairs Management Relationship Building Research Documents Safety-Oriented Scientific Research Standard Scientific Processes and Procedures Strategic Change Study Management

The anticipated base pay range for this position is :

$117000.00 - $201250.00

For Bay Area:

$134000.00 - $231150.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys long-term incentive program.



Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

Holiday pay including Floating Holidays 13 days per calendar year

Work Personal and Family Time - up to 40 hours per calendar year

Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Staff IC